MAUDE Adverse Event Report: ALLERGAN NATRELLE 410 BIOCELL HIGHLY COHESIVE SILICON BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Bacterial Infection (1735); Fever (1858); Pyrosis/Heartburn (1883); Itching Sensation (1943); Memory Loss/Impairment (1958); Nausea (1970); Pain (1994); Tachycardia (2095); Burning Sensation (2146); Hot Flashes/Flushes (2153); Electrolyte Imbalance (2196); Myalgia (2238); Anxiety (2328); Arthralgia (2355); Depression (2361); Diaphoresis (2452); Sleep Dysfunction (2517); Cognitive Changes (2551); Unspecified Mental, Emotional or Behavioural Problem (4430); Unspecified Gastrointestinal Problem (4491); Premature Menopause (4496); Breast Discomfort/Pain (4504); Increased Sensitivity (4538); Contact Dermatitis (4546); Increased Appetite (4570); Swelling/ Edema (4577)

Event Date 06/21/2016

Event Type  Injury  

Event Description

Patient called to report adverse events involving her allergan tissue expander and silicone breast implant.Patient stated the tissue expander was implanted in (b)(6) of 2016 and three months later had the silicone breast implant placed in (b)(6) of 2016.Patient stated about 2-3 months after the tissue expander was placed, she started experiencing right hip pain, bilateral hip pain that spread to her lower back, small joints, and large joints.Patient also experienced the following symptoms: muscle pain, ventricular tachycardia, irritable bowel syndrome, dermatitis, recurring bacterial vaginosis, sleep problems, anxiety, depression, cognitive and behavioral problems, problems with memory and processing, gluten intolerance, reflux, gerd, interstitial cystitis, hunger, nausea, endocrine problems, hot flashes, night sweats, early menopause, heat and cold sensitivity, and magnesium deficiency.Patient also stated in (b)(6) of 2018 she had swelling of her breast, she said it was hot, burning, tingling, painful, itchy and she had a low-grade fever.Patient said she went to the er and was given antibiotics, and everything cleared up within 72 hours, however she said she never had any testing to confirm if it was an infection.

• Brand Name: NATRELLE 410 BIOCELL HIGHLY COHESIVE SILICON BREAST IMPLANT
• Type of Device: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
• Manufacturer (Section D): ALLERGAN
• MDR Report Key: 14935056
• MDR Text Key: 295449497
• Report Number: MW5110698
• Device Sequence Number: 2
• Product Code: LCJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/05/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 53 YR
• Patient Sex: Female